Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen® and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations.

Like most pharmaceuticals, Ampligen does nothing to permanently correct the immune dysfunction in CFS, because it does not address the causes of said immune dysfunction, which can be many, and differ from patient to patient.

Sure, some patients have had remarkable improvement while on the drug, but as soon as they have stopped, their CFS relapses to a state even worse than the original condition they were so desperate to recover from. From wheelchair to a full life, and then bedridden again.

This is a fact. Google Mary Schweitzer, just as one example. Her 10 year history with this drug shows what a miserable and cruel failure it is, and an incredibly expensive one at that, fortunately putting it out of the reach of most CFS patients.

And we wonder why health”care” is so expensive.

http://www.hemispherx.net/content/investor/default.asp?goto=298

A letter was sent to all major news networks worldwide in which investors will be taking on the SEC, FTC and the Office of the President challenging them to reply. It will cover possible stock manipulation and back door disbursement of profits, specific to recent activity of The Street.com and its contributors, namely Adam Feuerstein who was instrumental in using public media and the internet to transmit false reports on several Bio stocks. It should be known that price drop and hedge fund purchases mysteriously coincided with the drops and immediately followed the post articles on The Street.com website. Specific to the demand for a public reply is as follows: Why did monitoring agencies question the CEO of Hemispherx Bio (HEB) about the sudden rise in stock price 8 days ago, while when the stock experienced a loss at greater than that rise rate, did not question the “reporter” at The Street.com as to their involvement in possible short selling, hedge fund involvement and price manipulation. Ironically Jim Cramer has recently begun a formal “short selling” petition that he publicly touted on his Mad Money CNBC show. Is this a ploy to mask his own activity and those of his financial circles to hide behind? ( see video for reference http://www.youtube.com/watch?v=HRa0B34jM... The clips seemed to strike a sour tone to CNBC and many of the clips were removed. Is CNBC actively aware of background manipulation tactics used by The Street and many who are within their circles? Could it be very possible that stock manipulation goes further than the halls of wall street and those involved were able to get embedded deep into the SEC and FTC so that only the privileged who hide behind the “Freedom of Speech” clause can avoid prosecution? It is time that the oval office become more aware of issues that go further than the political sectors and begin cleaning house where it’s needed. I say, yes, Mr. President, I will challenge you as well to reply to me via this board. Your platform is change; I myself voted for you and have no fear of making that public. I too see the future as one that requires change, and not only from the bottom up but also from the top down. My goal on Monday will be to make these challenges very public in whatever means it takes to achieve it. If it means that entities and individuals and The Street.com become the pinnacle of an in-depth investigation, so be it. It is owed to the American people for the President to become responsive to issues that make a difference to all people in America, regardless of class, celebrity status, or political affiliation. To this end, I will see that this exercise does not fall on deaf ears and mark my words, these events will be investigated and should Adam Feuerstein or Mr. Cramer be found guilty of any charges on a federal level it would be incumbent on all who have experienced financial losses to bring charges against these same individuals and the vehicles of media they are employed by, specifically NBC, GE (Owner of NBC and its affiliates. This notion is made on the basis that enough posts were made on this and other financial boards to make it so that CNBC and other management of NBC affiliated media sources were apprised of possible illegal movement within their organization and if it was not addressed or can be proved to have been addressed, that NBC and its owners and affiliates will be held liable for the compensation of all losses to shareholders and be held accountable for and not limited to criminal and civil penalties. Copy and communicate this release to as many of the boards or media sources that you are associated with on or before Monday. Thank you all in advance for your support and hope that we can begin to rid Wall street of criminals who are at the forefront of the corruption that helped put the United States in the unwanted financial crisis we are all experiencing.

My position: Long on HEB … I know it is important to all of us as Americans for Ampligen to be approved however we must put the FDA approval into a global perspective. Even if it is not approved for US distribution I believe short term it would be of no consequence to the value behind HEB. I make this presumption simply based on the inherent distribution probabilities outside our shores and the populations demand therein. The US population is a mere 4.53% or the world. The Asian rim and other countries that have already focued on Ampligen as a viable drug for various ailments constitue over 38% of the world population. (http://en.wikipedia.org/wiki/List_of_countries_by_population ) As Americans we should be used to our Admins and Commissions to sit in a bath of political rhetoric which stifles progress on the US. Too often we rely on outside countries to excel and later ponder what we did wrong and probably assign a new useless commission to do that. I think HEB and the Ampligen product will prevail, if not in the US, then for other countries.

There are 38 people in the NJ- HEB facility alone. I’ve managed an FDA and EPA certified manufacturing company which attained Malcolm Baldrige National Quality Award and ISO status with full utilization of GMP and MRP 1 & 2 production methods. My staff was half of what is listed as the manufacturing employees that HEB has in the NJ location and we were able to support orders received from company in the USA, Asia, Europe, South America and Canada. For those of you who don’t know the mechanical process of fill and seal machines, the typical machines used are Circle Line Form fill and Seal caddy stations capable of over 40,000 units per hour output. The manpower requirement for each shift per machine is 2 units with a staff mechanic covering the floor as needed all in a Class 100 or better environment. With that said, HEB has ample staffing for a full 3 shift schedule. The balance would be supervisory management, quality control and second tier management. For those of you who do not have a manufacturing background, the Baldrige Award is one of the highest honors a manufacturing company can receive. Thank you…Vinthetoolman@yahoo.com .